This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars & Animal Health. Check out our full report below:   

AbbVie Reports P-III (MIRASOL) Trial Data of Elahere for FRα-Positive Platinum-Resistant Ovarian Cancer (PROC) 

Read More: AbbVie 

Incyte Reports Topline Data from P-III (STOP-HS1 & STOP-HS2) Trials of Povorcitinib (INCB054707) for Hidradenitis Suppurativa (HS) 

Read More: Incyte 

Amgen Reveals P-III (MINT) Study Data of Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis (gMG) 

Read More: Amgen  

AstraZeneca Reports P-III (CALYPSO) Trial Data of Eneboparatide for Chronic Hypoparathyroidism (HypoPT) 

Read More: AstraZeneca 

Innovent and HUTCHMED Report P-II/III (FRUSICA-2) Trial Data of Sintilimab + Fruquintinib for Metastatic Renal Cell Carcinoma (RCC) 

Read More: Innovent and HUTCHMED 

Novartis Reports P-III (STEER & STRENGTH) trials data of OAV101 IT for Spinal Muscular Atrophy 

Read More: Novartis 

BMS Reports the EC’s Approval of Breyanzi to Treat R/R Follicular Lymphoma 

Read More: BMS 

AstraZeneca Reports the EC’s Approval of Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC) 

Read More: AstraZeneca 

Bayer Reports the US FDA’s sNDA Acceptance & Priority Review of Finerenone for Heart Failure (HF) 

Read More: Bayer 

Innovent Reports the NMPA Approval of Sycume for Thyroid Eye Disease 

Read More: Innovent 

Alnylam Pharmaceuticals Reports the US FDA’s Approval of Amvuttra (Vutrisiran) to Treat ATTR Amyloidosis with Cardiomyopathy (ATTR-CM) 

Read More: Alnylam Pharmaceuticals 

Novartis Reports the US FDA’s Approval of Fabhalta (Iptacopan) to Treat C3 glomerulopathy 

Read More: Novartis 

Johnson & Johnson Reports the US FDA’s Approval of Subcutaneous & Intravenous Tremfya for Active Crohn’s Disease (CD) 

Read More: J&J 

HUTCHMED Receives NMPA’s Conditional Approval for Tazverik to Treat R/R Follicular Lymphoma 

Read More: HUTCHMED 

AstraZeneca and Alteogen Enter an Exclusive License Deal for ALT-B4 to Develop & Market Subcutaneous Formulations of Multiple Oncology Drugs 

Read More: AstraZeneca and Alteogen 

NANOBIOTIX and Janssen Amend Partnership to Develop and Commercialize JNJ-1900 (NBTXR3) 

Read More: NANOBIOTIX and Janssen 

Oxford BioTherapeutics and Roche Collaborate to Discover Next-Gen Biologics for Cancer Treatment 

Read More: Oxford BioTherapeutics and Roche jnj

Servier Collaborates with Black Diamond Therapeutics to Advance BDTX-4933 for Solid Tumors 

Read More: Servier and Black Diamond Therapeutics 

Sanofi to Acquire Dren Bio’s Bispecific Antibody DR-0201 for ~$1.9B 

Read More: Sanofi and Dren Bio 

Perfuze Secures the US FDA’s 510(k) Clearance for its Zipline Access Catheters 

Read More: Perfuze 

bioMérieux Reports the US FDA’s 510(k) Clearance of VITEK COMPACT PRO for Pathogen Detection & Antibiotic Susceptibility Testing 

Read More: bioMérieux 

Orthofix Medical Receives US FDA’s 510(k) clearance & European CE Mark for its TrueLok Elevate Transverse Bone Transport (TBT) System 

Read More: Orthofix Medical 

Moon Surgical Reports US FDA’s 510(k) Clearance of ScoPilot to Improve Intraoperative Capability 

Read More: Moon Surgical 

AstraZeneca to acquire EsoBiotec for ~$1B 

Read More: AstraZeneca and EsoBiotec 

Endo & Mallinckrodt Pharmaceuticals to Form a Combine Entity with $6.7B Cash-and-Stock 

Read More: Endo & Mallinckrodt Pharmaceuticals 

Taiho Pharmaceutical to Acquire Araris Biotech for ~$1.1B 

Read More: Taiho Pharmaceutical and Araris Biotech 

Paratek Pharmaceuticals to Acquire Optinose for ~$330M, Expanding its Commercial Portfolio 

Read More: Paratek Pharmaceuticals and Optinose 

Elanco and WEDterinary Collaborate to Develop Novel Therapies for Pets 

Read More: Elanco and WEDterinary 

ELIAS Animal Health Reports USDA’s Full Approval of ELIAS Cancer Immunotherapy (ECI) for Canine Osteosarcoma 

Read More: ELIAS Animal Health 

Alvotech and Dr. Reddy’s Report the US FDA’s BLA Acceptance for AVT03 (Biosimilar, Prolia and Xgeva) 

Read More: Alvotech and Dr. Reddy’s 

Related Post: PharmaShots Weekly Snapshots (March 10, 2025 – March 13, 2025)